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Clinical Trial NCT05988645 for Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma, Colorectal Neoplasms is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II) 50
Clinical Trial NCT05988645 is an interventional study for Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma, Colorectal Neoplasms that is recruiting. It started on 1 August 2023 with plans to enroll 50 participants. Led by MiWEndo Solutions S.L., it is expected to complete by 29 December 2025. The latest data from ClinicalTrials.gov was last updated on 29 September 2025.
Brief Summary
The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an ...Show More
Detailed Description
This study is designed as a single-center prospective, non-comparative study in 50 patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis).
In this study the principal aims are to assess the performance and safety of the device for the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims...
Show MoreOfficial Title
Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
Conditions
Colorectal CancerColorectal PolypColorectal AdenomaColorectal Adenomatous PolypColorectal AdenocarcinomaColorectal NeoplasmsOther Study IDs
- MW II-CIP
NCT ID Number
Start Date (Actual)
2023-08-01
Last Update Posted
2025-09-29
Completion Date (Estimated)
2025-12-29
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
microwave imaging
colonoscopy
early diagnosis
colorectal cancer screening
colonoscopy
early diagnosis
colorectal cancer screening
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalMiWEndo + colonoscope All patients will be explored with MiWEndo as an accessory to colonoscopy | MiWEndo System All colonoscopies will be performed with high-definition technology. The MiWEndo System will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System. The MiWEndo Analyzer will be managed by the assistant.
At the beginning of the extubatio...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of polyps | With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients. | During the procedure. |
Number of adverse events. | Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54). | During the procedure and up to 2 weeks after. |
Number of mural injuries. | Mural injuries related with the use of the MiWEndo. | During the procedure and up to 2 weeks after. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number and size (adenomas and polyps). | The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy. | During procedure. |
True positives (TP), False positives (FP), False negatives (FN). | The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN). | During procedure. |
Patients' comfort. | Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort). | Immediately after the procedure and 2 weeks after. |
Perception of difficulty. | Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little). | Immediately after the procedure. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Patients with a previously detected polyp in the rectum referred for resection.
These criteria will ensure the probability of finding polyps during the explorations.
All the patients will give written informed consent.
- Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
- ASA-IV patients.
- Urgent colonoscopy.
MiWEndo Solutions S.L.No contact data.
1 Study Locations in 1 Countries
Hospital Clinic, Barcelona, Spain
Glòria Fernández, Contact, 0034626710677, [email protected]
Recruiting